Field
The present application relates to packaging for an intra-vascular device and method. More particularly, the present application relates to packaging for a device for treatment of intra-vascular diseases and related methods.
Description of the Related Art
The current commercial catheter delivery product families utilize single or dual flexible pouches to create the sterile barrier. A separate thermoformed device tray secures the delivery system within the pouches. This approach is not ideal for devices of this length, total weight, and weight distribution. Vibration and shock during handling and delivery place significant stress on the barrier. The device tray can abrade the inner pouch. Repetitive flexing of the pouch especially at the confluence of multiple (compound) folds causes stress cracking and pin holes.
Given that each device may experience multiple delivery cycles before use, e.g., shipment back and forth, the sterile barrier margin of safety may be lower than preferred. The current pouch sterile barrier system has shown to be very challenging to develop and prove through validation testing.
Aseptic transfer difficulties arise from pouch-based sterile barriers. Nursing staff have demonstrated their challenges openings and presenting the device into the sterile field. The close proximity of the nonsterile pouch faces to the sterile surfaces makes the likelihood of contamination higher than ideal. The method used to open and present the device varies between nurses and facilities, some showing frustration and poor technique.
Pouch designs are inherently inefficient in regards to space and material. Cartons must be designed oversize, leading to excess material usage, inventory, and shipping overhead. Depending on the application, neither the pouches nor the tray can ultimately be recycled.